A Compassionate Use/Expanded Access Protocol Using 131I-MIBG Therapy for Patients With Refractory Neuroblastoma and Metastatic Pheochromocytoma
This is an expanded access protocol/compassionate use single institution study designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher priority. Response rate, toxicity, and time to progression and death will be evaluated.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|Eligible Ages||365 Days - 29 Years|
- - Diagnosis: Relapsed/Refractory neuroblastoma, with an original diagnosis made histologically or from elevated urine catecholamines with abnormal tumor cells in bone marrow OR relapsed/refractory pheochromocytoma.
- - Disease status: Progressive disease at any time (defined as any new lesion or an increase in size by >25% of pre-existing disease), or a failure to respond to standard therapy.
- - Prior therapy: A minimum of two weeks since should have elapsed since any chemotherapy causing myelosuppression.
- - Organ function: ANC >500/uL, platelets >20,000/uL with transfusion allowed.
- - Stem cells: Patients must have a minimum of 2.0 x106/kg viable CD34+ peripheral blood stem cells for re-infusion following 131I-MIBG.
- - Life expectancy longer than 8 weeks,Karnofsky or Lansky performance status of ≥ 50%
Exclusion Criteria:- Pregnant or lactating patients.
- - Disease of any organ system that would compromise the patient's ability to participate in the study, including hemodialysis.
- - Patients with active grade 3-4 infection, as defined by the NCI CTCAE V4.0.
- - Patients with known MBIG-avid brain parenchymal disease (leptomeningeal or skull based metastases are eligible).
- - In patients with metastatic pheochromocytoma, a urinalysis must be preformed prior to study enrollment.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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|Principal Investigator Affiliation||N/A|
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Cohen Children's Medical Center
New Hyde Park, New York, 11040